Cleared Traditional

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset (K210661) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210661 · Quanta Dialysis Technologies, Ltd. · Gastroenterology & Urology device
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Aug 2021
Decision
161d
Days
Class 2
Risk

K210661 is an FDA 510(k) clearance for the SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Quanta Dialysis Technologies, Ltd. (Alcester, GB). The FDA issued a Cleared decision on August 12, 2021 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quanta Dialysis Technologies, Ltd. devices

Submission Details

510(k) Number K210661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2021
Decision Date August 12, 2021
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 77
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K210661.
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Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
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Revaclear 500, Revaclear 400, Revaclear 300
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AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory
K201809 · Baxter Healthcare Corportation · Mar 2021
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
K203062 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2020
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K193670 · Quanta Dialysis Technologies, Ltd. · Dec 2020